1332P - A randomized phase II trial of standard versus low-dose nab-paclitaxel for previously treated advanced non-small cell lung cancer (JMTO LC14-01)

Background

Nanoparticle albumin-bound (nab) paclitaxel is an active agent for non–small cell lung cancer (NSCLC). Nab-paclitaxel proved to be noninferior to docetaxel with regard to overall survival (OS), having showcased improved progression-free survival (PFS) and overall response rate (ORR) in patients with previously treated advanced NSCLC, according to findings from the phase III trial in Japan (J-AXEL study, 2021). In chemotherapy for advanced NSCLC, it is expected that administration of the optimal dose for as long as possible will lead to improvement of prognosis rather than administration of the maximum tolerated dose for a short period of time. We designed a randomized phase II study to examine the clinical benefit and safety of nab-paclitaxel in patients with previously treated advanced NSCLC.

Methods

Patients were randomly allocated (1:1) to receive nab-paclitaxel at 100 mg/m² on days 1, 8, and 15 every 4 weeks (group A) or nab-paclitaxel at 70 mg/m² on days 1, 8, and 15 every 4 weeks (group B). The primary endpoint was PFS. Secondary endpoints included OS, ORR and adverse events.

Results

A total of 81 patients were randomized. No statistical difference was observed between the arms (group A versus group B) for PFS (3.75 versus 3.71 months, hazard ratio [HR] = 0.76 [95% confidence interval (CI) 0.47–1.23]), OS (13.50 versus 16.13 months, HR = 0.93 [95% CI 0.52–1.67]), or best ORR (20.5% versus 23.1% [P = 1.000]). The incidence of grade 3 or worse adverse events were 23 patients [57.5%] in group A and 17 patients [41.5%] in group B. The proportion of subjects who developed serious side effects was 10.0% in group A (4 out of 40) and 4.9% in group B (2 out of 41). The proportion of subjects who developed adverse events leading to death was 2.5% in group A (1 in 40) and 2.4% in group B (1 in 41). However, most toxicities were manageable with appropriate dose reductions and supportive care.

Conclusions

Both 100 mg/m² and 70 mg/m² of nab-paclitaxel monotherapy are active for patients with previously treated advanced non-small cell lung cancer, with better safety profile and numerically favored OS and ORR for 70 mg/m² dose. Therefore, 70 mg/m² would be the optimal dose of nab-paclitaxel for NSCLC.

Clinical trial identification

jRCTs031180214.

Editorial acknowledgement

This work was supported by Taiho Pharmaceutical Co. Ltd.

Legal entity responsible for the study

The Japan-Multinational Trial Organization.

Funding

Taiho Pharmaceutical Co. Ltd.

Disclosure

S. Takeuchi: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. Ltd. S. Sugawara: Financial Interests, Institutional, Invited Speaker: Taiho Pharmaceutical. M. Seike: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. Ltd.; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical Co. Ltd. A. Gemma: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. Ltd.; Financial Interests, Personal, Research Grant: Taiho Pharmaceutical Co. Ltd. K. Kubota: Financial Interests, Personal, Invited Speaker: Taiho Pharmaceutical Co. Ltd.; Financial Interests, Personal, Advisory Board: Taiho Pharmaceutical Co. Ltd. All other authors have declared no conflicts of interest.